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FDA 510(k)

BrainPulse 1100

K-Number: K170926 · 2017-04-28

ApplicantJan Medical, Inc.
Decision Date2017-04-28
Product CodePOP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BrainPulse 1100 is the device name listed in this FDA 510(k) record. The listed applicant is Jan Medical, Inc.. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K170926. The device is classified under product code POP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BrainPulse 1100?

BrainPulse 1100 is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Jan Medical, Inc.. The 510(k) number is K170926.

When did BrainPulse 1100 receive FDA 510(k) clearance?

BrainPulse 1100 received FDA 510(k) clearance on 2017-04-28, under 510(k) number K170926.

Who is the listed applicant for BrainPulse 1100?

The FDA 510(k) record lists Jan Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BrainPulse 1100?

The FDA product code for BrainPulse 1100 is POP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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